Cigar Reference Products Program

雪茄参考产品计划

• 批准号: 10328222
• 负责人: Orlando Chambers
• 金额: $ 100万
• 依托单位: UNIVERSITY OF KENTUCKY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-02-01 至 2025-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10328222
• 关键词: Cigar; Reference; Products; Program

Project Summary/Abstract: Since 1968 the University of Kentucky has provided reference tobacco products as standards for non-clinical investigational purposes by tobacco manufacturers, contract and government laboratories, and academic institutions. This project will produce and characterize machine made, sheet-wrapped cigar tobacco reference products representative of large cigars (processed leaf filler, non-premium), little cigars (brown cigarettes) and small cigars (cigarillos). These new certified reference products will be manufactured in one manufacturing run each, to ensure product uniformity, and will have certified physical and chemical characteristics to allow for proficiency testing, instrument calibration, employee/student training, and for method validation and investigational purposes. A process for the design, analysis, and approval is included to ensure input from stakeholders and that the new cigar reference tobacco products meet the specified goals. Quality control and sample testing parameters are defined and substantial chemical analyses will be conducted to allow for certification of product characteristics and constituent levels. The CTRP will advance efforts to collaborate and coordinate studies with stakeholders, including Tobacco Centers for Regulatory Science, commercial product testing laboratories, tobacco product manufacturers, and academic researchers. This proposal outlines significant improvements to current cigar tobacco reference products in terms of product design and certification, product distribution, product storage, planning for new reference tobacco products, establishing research capability and providing new services that will benefit the tobacco research community. A web- based interface for ordering reference tobacco products and for the secure transmission and storage of collaborative data is under development and will be enhanced to include the cigar reference products. The CTRP web-based solution and database will be migrated to a Cloud environment to scale resources to meet future demand, while reducing operational costs and increasing the effectiveness of IT processes and personnel. As an academic institution, our proposal will be a service to the entire tobacco research community and is an improvement over current efforts to coordinate and administer inter-laboratory comparison studies on tobacco reference products and mechanisms to provide various cigar tobacco reference products. The development of high-quality cigar tobacco reference products and providing those through the CTRP will strengthen the FDA’s effort to develop the science of tobacco regulation and provide a much needed basic resource for tobacco product research and regulation.

项目摘要/摘要：自1968年以来，肯塔基大学提供了参考 烟草产品作为烟草制造商非临床研究目的的标准， 合同和政府实验室以及学术机构。这个项目将产生并 表征机器制造的机器，包裹雪茄烟草参考产品代表 大雪茄（加工叶填充物，非高级），小雪茄（棕色香烟）和小雪茄 （雪茄）。这些新的认证参考产品将在一次制造业中生产 每个，确保产品均匀性，并具有认证的物理和化学特征 允许熟练测试，仪器校准，员工/学生培训以及方法 验证和研究目的。设计，分析和批准的过程是 包括为了确保利益相关者的意见和新的雪茄参考烟草产品 实现指定目标。定义了质量控制和样本测试参数，并 将进行大量的化学分析以允许使用产品特性认证 并构成水平。 CTRP将促进与利益相关者合作和协调研究的努力，包括 监管科学，商业产品测试实验室，烟草产品的烟草中心 制造商和学术研究人员。该提案概述了 当前的雪茄烟草参考产品在产品设计和认证方面，产品 分销，产品存储，新参考烟草产品的计划，建立研究 网络 - 用于订购参考烟草产品以及安全传输和的基于订购的界面 协作数据的存储正在开发中，并将得到增强以包括雪茄 参考产品。基于CTRP Web的解决方案和数据库将迁移到云 扩展资源以满足未来需求的环境，同时降低运营成本和 提高IT过程和人员的有效性。作为一个学术机构，我们 提案将为整个烟草研究社区提供服务，并且是对 目前的努力协调和管理烟草间比较研究 参考产品和机制提供各种雪茄烟草参考产品。 开发高质量的雪茄烟草参考产品，并通过 CTRP将加强FDA开发烟草监管科学的努力，并提供 烟草产品研究和法规的急需基本资源。